BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 16162466 · Received January 13, 2023

    Report

    Report Number
    3012236936-2023-00021
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 14, 2022
    Report Date
    January 13, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474750531
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE IMPLANTED: NOT APPLICABLE, AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. DATE EXPLANTED: NOT APPLICABLE, AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. IT WAS INDICATED THAT THE IOL IS NOT BEING RETURNED FOR EVALUATION AS IT WAS DISCARDED THEREFORE, A VISUAL ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND HISTORICAL DATA ANALYSIS FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. HEALTH EFFECT - IMPACT CODE: 4631 IOL REMOVAL AND REPLACEMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DFR00V WAS INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) WHEN A SCRATCH WAS NOTED BY THE SURGEON. THE IOL WAS PREPARED APPROPRIATELY BY THE TECHNICIAN IN THE ROOM WITH BALANCED SALT SOLUTION (BSS). IOL WAS REMOVED WITH MICRO SURGICAL TECHNOLOGY (MST) FORCEPS AND REPLACED WITH BACK UP LENS, WHICH WAS THE SAME MODEL AND DIOPTER SIZE. NO ADVERSE EFFECTS HAVE BEEN NOTED BY THE DOCTOR. THE DFR00V IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS: NO ADVERSE EFFECTS NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528525 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V 05050474750531

    Patients

    Seq Age Sex Outcome Treatment
    1 Female